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ORIGINAL RESEARCH article

Front. Public Health
Sec. Digital Public Health
Volume 12 - 2024 | doi: 10.3389/fpubh.2024.1508166

Decentralized Clinical Trials are better for the participants and for the planet: The case study of a double-blind randomized controlled trial in Singapore (PROMOTE Study)

Provisionally accepted
Lisa R. Fries Lisa R. Fries 1Nadia Khaled Nadia Khaled 2Ivan Viveros Santos Ivan Viveros Santos 3Elvira Suniega-Tolentino Elvira Suniega-Tolentino 4Motshewa Sesing Motshewa Sesing 2,5*Melissa P.S. Toh Melissa P.S. Toh 6Chui Yuen Yang Chui Yuen Yang 6Shiao Yng Chan Shiao Yng Chan 6,7Sara Colombo Mottaz Sara Colombo Mottaz 2
  • 1 Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Beijing, China
  • 2 Clinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland
  • 3 CIRAIG, Chemical Engineering Department, Polytechnique Montréal, Montreal, Canada
  • 4 Clinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A.,, Singapore, Singapore
  • 5 Nestle Institute of Health Sciences (NIHS), Lausanne, Vaud, Switzerland
  • 6 Singapore Institute for Clinical Sciences (A*STAR), Singapore, Singapore
  • 7 Department of Obstetrics and Gynaecology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore

The final, formatted version of the article will be published soon.

    A fully decentralized clinical trial conducted in Singapore is used as a case study to evaluate the operational outcomes, environmental impact (via life cycle assessment), and participants experience (qualitative interviews) of the decentralized model compared to a traditional study with in-person visits. The decentralized study achieved high participant retention rates (97%) and high completion rates for clinical data, even for biological samples. Participants found the decentralized model to be convenient and safe, especially during the pandemic. Moreover, the decentralized model was found to be more environmentally friendly and less detrimental to human health compared to traditional face-to-face clinical trials, primarily by reducing participants' use of cars for site visits. While this study focused on the environmental impact, it is important to consider other factors such as participant safety, convenience, and data quality when evaluating the suitability of a decentralized clinical trial approach. Careful planning of data flow, database structure, and data protection measures is essential. This study contributes to improving the environmental footprint of clinical trials. Environmental sustainability should be among the factors that are evaluated when selecting trial models. Decentralized and hybrid clinical trials offer efficiency, effectiveness, and environmental benefits. Further research and adoption of these approaches are encouraged.

    Keywords: decentralized clinical trial, rct, Environmental impact, Life-cycle Assessment, Maternal health, research participant experience

    Received: 08 Oct 2024; Accepted: 27 Dec 2024.

    Copyright: © 2024 Fries, Khaled, Viveros Santos, Suniega-Tolentino, Sesing, Toh, Yang, Chan and Colombo Mottaz. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Motshewa Sesing, Nestle Institute of Health Sciences (NIHS), Lausanne, 1015, Vaud, Switzerland

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.